Isotonic Versus Hypotonic Fluid for Maintenance IV Therapy
Status:
Completed
Trial end date:
2008-04-01
Target enrollment:
Participant gender:
Summary
Hyponatremia associated with administration of hypotonic intravenous (IV) fluids may have
serious complications. It has recently been suggested that isotonic saline may be a more
appropriate choice of maintenance IV fluid. This pilot and feasibility study aims to compare
isotonic saline to 0.45% saline in hospitalized children requiring parenteral fluid support
in order to:
Aim 1: To determine the feasibility of conducting a double-blind, randomized controlled trial
comparing these solutions.
Aim 2a: To compare the rate of change in serum Na (mmol/L/hr) and the incidence of
hyponatremia (Na <136 mmol/L) between patients receiving isotonic and hypotonic intravenous
fluids at at least 50% of the traditional maintenance rate for an interval of at least 8
hours.
Aim 2b: To compare the incidence of adverse events between the two IV fluid treatment groups.
Phase:
Phase 3
Details
Lead Sponsor:
McGill University Health Center McGill University Health Centre/Research Institute of the McGill University Health Centre